S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
18 Years
N/A
Both
Stage 0 Cervical Cancer, High-grade Squamous Intraepithelial Lesion
Trial Information
S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
OBJECTIVES:
- Compare the complete response rate in patients with high-grade squamous intraepithelial
lesions of the cervix treated with celecoxib vs placebo.
- Compare the toxicity of these drugs in these patients.
- Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and
human papilloma virus expression in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to high-grade squamous intraepithelial lesion status (cervical
intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral celecoxib twice daily for 1 month.
- Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment
repeats monthly for 3 courses in the absence of disease progression or unacceptable
toxicity. All patients then undergo loop electrosurgical excision procedure or cone
biopsy to determine response.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 1-2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed high-grade squamous intraepithelial lesions (HGSIL) of the
cervix
- Cervical intraepithelial neoplasia (CIN) 2 (moderate dysplasia) OR CIN 3 (severe
dysplasia, carcinoma in situ)
- Must have remaining HGSIL after biopsy
- No suspicion of invasive cancer by colposcopy within the past 28 days
- No invasive or preinvasive high-grade intraepithelial neoplasia by endocervical
curettage within the past 56 days
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- SGOT and SGPT less than 2.0 times upper limit of normal (ULN)
- Bilirubin less than 2.0 times ULN
Renal
- Creatinine less than 2.0 mg/dL
Immunologic
- No prior asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs
- No allergy to sulfonamides
- No known sensitivity to celecoxib
- No known AIDS or HIV-associated complex
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or adequately treated stage I or II cancer currently in
complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 3 months since prior topical medications for genital condyloma
- No prior treatment for squamous intraepithelial lesions
- No concurrent topical medications for genital condyloma
- No other concurrent treatment
- No concurrent chronic (daily for more than 30 days) aspirin
- No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
William R. Robinson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Harrington Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000340176
NCT ID:
NCT00072540
Start Date:
Completion Date:
Related Keywords:
- Stage 0 Cervical Cancer
- High-Grade Squamous Intraepithelial Lesion
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
Name | Location |
|---|
